Government Affairs
Idaho Technology Delivers BioThreat Detection Kit for US Military
Idaho Technology Inc. has delivered its first shipment of the RAZOR CRP BioThreat-X Kits to the Critical Reagents Program (CRP) which supplies test reagents to the US military. The RAZOR CRP BioThreat-X Kit represents the first U.S. Department of Defense (DoD) system capable of testing for 10 biothreat agents at one time in the field with results available in 30 minutes. The RAZOR CRP BioThreat-X Kit contains polymerase chain reaction (PCR) assays developed in DoD laboratories. These assays are...
IschemiaCare Receives State Loan for Stroke Test
MedCity News reported that a startup that’s hoping to be the first to commercialize a blood test that can diagnose the cause of stroke has received a state loan for nearly $1 million. The $943,000 in financing for Cincinnati-area IschemiaCare comes through the Innovation Ohio Loan Fund program, which is aimed at helping companies in the state develop next-generation products. IschemiaCare‘s project funded through the loan is expected to create 22 jobs, according to the Ohio...
Quanterix Receives DHS Funding for Botulism Test
Quanterix Corp. has been awarded a one year $250,155 contract from the Department of Homeland Security (DHS) to develop an assay capable of detecting single molecules of botulinum toxin (BoNT) within complex environmental samples. In collaboration with the Botulinum Research Center (BRC) at UMass Dartmouth, Quanterix will develop and validate a high sensitivity assay capable of measuring extremely low levels of the BoNT agent. "The detection of low copy numbers of toxins and pathogenic...
Federal Contract Awarded to Oxford Diagnostic Laboratories for TB Testing
Oxford Immunotec Inc. announced that the National Acquisition Center of the Department of Veterans Affairs has awarded a Federal Supply Schedule contract to Oxford Diagnostic Laboratories for T-SPOT.TB testing. This contract will be effective from November 1, 2011 through October 31, 2016. Oxford Diagnostic Laboratories, a division of Oxford Immunotec, is the only national TB testing service exclusively dedicated to the T-SPOT.TB test. The laboratory,...
Roche Predicts Govt. Austerity Will Prompt Growth in Companion Diagnostics
Bloomberg published a story yesterday in which Roche says it expects government austerity strategies to benefit Roche's diagnostics unit in the next three to five years, thanks to broader use of tests to see which patients should receive expensive treatments. Roche Diagnostics' COO, Daniel O’Day, told Bloomberg that he expects the number of tests to help single out the patients who will benefit most from Roche’s therapeutics will double within two to three years. “No country...
Appeals Court Rules That Companies May Patent Breast Cancer Genes
In a 2-1 decision, a federal appeals court partially reversed a lower court’s ruling in a case challenging patents on two human genes associated with hereditary breast cancer and ovarian cancer. The court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences. The ruling follows a lawsuit brought by a group of patients and scientists represented by the American Civil Liberties Union and the Public Patent Foundation (PUBPAT) and calls...
Supreme Court Sides with Roche
According to GenomeWeb Daily News, the Supreme Court ruled that Stanford University does not have a claim to PCR technology-related patents that it said Roche Molecular Systems has infringed. The decision will serve to clarify the domain of the 1980 Bayh-Dole Act and will mean that going forward, it is likely that universities seeking to retain rights to patents from their employees will need to have an agreement that assigns the school those rights. In a 7-2 decision, the court sided with...
FDA releases draft guidance for RUO/IUO IVDs
FDA has issued a draft guidance stating its recommended practices for using and marketing IVD tests for research and investigational uses only. "Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions" is now available for public comment. The document is "intended for manufacturers and distributors of RUO and IUO IVD products and any other entities who...
CDC Recognizes Newborn Screening in Ten Great Public Health Achievements
CDC announced its "Ten Great Public Health Achievements – United States, 2001-2010." The major public health achievements of the first 10 years of the 21st century included newborn screening in its widely announced list. CDC's report said, "Improvements in technology and endorsement of a uniform newborn screening panel of diseases have led to earlier life-saving treatment and intervention for at least 3,400 additional newborns each year with selected genetic and endocrine...
American Academy of HIV Medicine Hails Pennsylvania Senate's Passage of HIV Testing Bill
The American Academy of HIV Medicine (AAHIVM) praised the Pennsylvania State Senate for the passage of legislation sponsored by state Sen. Ted Erickson (R-26) that reduces barriers to routine HIV testing. The passage of Senate Bill 260 eliminates burdensome requirements for separate written consent and pre-test counseling in order to obtain an HIV test and brings Pennsylvania state law on HIV testing more in line with current recommendations from CDC. Currently, Pennsylvania is one of only five...